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Long-Term Safety of Febuxostat in Subjects With Gout. (FOCUS)

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ClinicalTrials.gov Identifier: NCT00174941
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : July 16, 2009
Last Update Posted : January 27, 2011
Sponsor:
Information provided by:
Takeda

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gout
Intervention Drug: Febuxostat
Enrollment 116
Recruitment Details Subjects were enrolled at 23 investigational sites in the United States from 21 March 2001 to 29 December 2006
Pre-assignment Details Subjects were to have completed 4 weeks of double-blind dosing in Study TMX-00-004 (NCT00174967) before enrollment in once daily (QD) treatment groups. Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description Febuxostat 40 mg, orally, once daily, based on serum urate level. Febuxostat 80 mg, orally, once daily, based on serum urate level. Febuxostat 120 mg, orally, once daily, based on serum urate level. [Not Specified]
Period Title: Overall Study
Started 8 [1] 79 [1] 29 [1] 116
Completed 6 41 11 58
Not Completed 2 38 18 58
Reason Not Completed
Adverse Event             1             10             2             13
Protocol Violation             0             1             0             1
Lost to Follow-up             0             3             2             5
Personal Reason(s)             0             14             8             22
Gout Flare             0             4             4             8
Reason Not Specified             1             6             2             9
[1]
Subjects started on febuxostat 80mg. Number of subjects based on Final Stable Dose after titration.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total
Hide Arm/Group Description Febuxostat 40 mg orally, once daily, based on serum urate level. Febuxostat 80 mg, orally, once daily, based on serum urate level Febuxostat 120 mg, orally, once daily, based on serum urate level Total of all reporting groups
Overall Number of Baseline Participants 8 79 29 116
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 8 participants 79 participants 29 participants 116 participants
<45 years 2 20 9 31
45 to <65 years 4 40 15 59
≥65 years 2 19 5 26
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 79 participants 29 participants 116 participants
54.5  (11.44) 53.9  (12.85) 51.3  (13.01) 53.3  (12.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 79 participants 29 participants 116 participants
Female
0
   0.0%
9
  11.4%
2
   6.9%
11.0
Male
8
 100.0%
70
  88.6%
27
  93.1%
105.0
History of Kidney Stone  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 8 participants 79 participants 29 participants 116 participants
Yes 0 11 3 14
No 8 68 26 102
Presence of Tophus  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 8 participants 79 participants 29 participants 116 participants
Yes 1 13 12 26
No 7 66 17 90
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 8 participants 79 participants 29 participants 116 participants
Asian 0 0 2 2
Black or African American 1 5 3 9
White 7 71 21 99
Hispanic 0 2 1 3
Other 0 1 2 3
Renal Function   [1] 
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 8 participants 79 participants 29 participants 116 participants
Normal 3 33 12 48
Impaired 5 46 17 68
[1]
Measure Description: Impaired renal function was defined as serum creatinine >1.5 milligrams per deciliter (mg/dL) or a creatinine clearance of ≤80 milliliters per minute (mL/min)
Urine Uric Acid  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 8 participants 79 participants 29 participants 116 participants
Underexcretor 5 62 21 88
Overproducer 3 16 7 26
Missing 0 1 1 2
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kiligram per meter² (kg/m²)
Number Analyzed 8 participants 79 participants 29 participants 116 participants
28.4  (2.78) 32.9  (5.28) 33.9  (6.82) 32.9  (5.69)
Serum Urate  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 8 participants 79 participants 29 participants 116 participants
9.58  (1.18) 9.48  (1.04) 10.23  (1.74) 9.7  (1.30)
1.Primary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit.
Hide Description Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 10 58 17 85
Measure Type: Number
Unit of Measure: percentage of subjects
50 93 65 82
2.Primary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit.
Hide Description Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 12 visit was summarized.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 7 55 18 80
Measure Type: Number
Unit of Measure: percentage of subjects
57 85 67 79
3.Primary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit.
Hide Description Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 18 visit was summarized.
Time Frame Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 8 50 14 72
Measure Type: Number
Unit of Measure: percentage of subjects
50 82 57 74
4.Primary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit.
Hide Description Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 24 visit was summarized.
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 8 49 13 70
Measure Type: Number
Unit of Measure: percentage of subjects
63 76 92 77
5.Primary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit.
Hide Description Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 36 visit was summarized.
Time Frame Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 6 45 13 64
Measure Type: Number
Unit of Measure: percentage of subjects
67 84 92 84
6.Primary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit.
Hide Description Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 48 visit was summarized.
Time Frame Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 6 39 13 58
Measure Type: Number
Unit of Measure: percentage of subjects
83 92 85 90
7.Primary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit.
Hide Description Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 60 visit was summarized.
Time Frame Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 6 41 11 58
Measure Type: Number
Unit of Measure: percentage of subjects
100 93 91 93
8.Primary Outcome
Title Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit.
Hide Description The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.
Time Frame Last Visit on treatment (up to 66 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 8 79 27 114
Measure Type: Number
Unit of Measure: percentage of subjects
100 82 81 83
9.Secondary Outcome
Title Percent Change in Serum Urate Levels From Baseline at Month 6 Visit.
Hide Description Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 10 58 17 85
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-35.9  (9.55) -50.6  (9.84) -47.6  (19.6) -48.3  (13.07)
10.Secondary Outcome
Title Percent Change in Serum Urate Levels From Baseline at Month 12 Visit.
Hide Description Serum urate values were obtained at the Month 12 visit. The percent change in serum urate from baseline to the Month 12 visit was summarized.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 7 55 18 80
Mean (Standard Deviation)
Unit of Measure: percentage of subjects
-35.0  (13.16) -49.7  (9.26) -49.3  (15.77) -48.3  (11.94)
11.Secondary Outcome
Title Percent Change in Serum Urate Levels From Baseline at Month 18 Visit.
Hide Description Serum urate values were obtained at the Month 18 visit. The percent change in serum urate from baseline to the Month 18 visit was summarized.
Time Frame Baseline and Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 8 50 14 72
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-35.5  (16.35) -48.7  (11.12) -39.5  (19.36) -45.4  (14.35)
12.Secondary Outcome
Title Percent Change in Serum Urate Levels From Baseline at Month 24 Visit.
Hide Description Serum urate values were obtained at the Month 24 visit. The percent change in serum urate from baseline to the Month 24 visit was summarized.
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 8 49 13 70
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-38.9  (19.41) -46.7  (11.59) -54.7  (12.02) -47.3  (13.24)
13.Secondary Outcome
Title Percent Change in Serum Urate Levels From Baseline at Month 36 Visit.
Hide Description Serum urate values were obtained at the Month 36 visit. The percent change in serum urate from baseline to the Month 36 visit was summarized.
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 6 45 13 64
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-43.0  (9.14) -46.9  (13.35) -56.4  (13.76) -48.4  (13.6)
14.Secondary Outcome
Title Percent Change in Serum Urate Levels From Baseline at Month 48 Visit.
Hide Description Serum urate values were obtained at the Month 48 visit. The percent change in serum urate from baseline to the Month 48 visit was summarized.
Time Frame Baseline and Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 6 39 13 58
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-50.0  (4.16) -50.3  (10.61) -53.8  (16.41) -51.1  (11.64)
15.Secondary Outcome
Title Percent Change in Serum Urate Levels From Baseline at Month 60 Visit.
Hide Description The secondary outcome was the mean percent change from baseline to Month 60 visit as assessed by serum urate levels collected at baseline and at the Month 60 visit by dose at observation.
Time Frame Baseline and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 6 41 11 58
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-45.5  (8.70) -51.1  (13.21) -59.0  (18.74) -52.0  (14.32)
16.Secondary Outcome
Title Percent Change in Serum Urate Levels From Baseline at Final Visit.
Hide Description The percent change in serum urate from baseline to the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.
Time Frame Baseline and Last Visit on treatment (up to 66 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Total Febuxostat
Hide Arm/Group Description:
Febuxostat 40 mg, orally, once daily, based on serum urate level.
Febuxostat 80 mg, orally, once daily, based on serum urate level.
Febuxostat 120 mg, orally, once daily, based on serum urate level.
[Not Specified]
Overall Number of Participants Analyzed 8 79 27 114
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
-49.2  (7.10) -47.1  (16.42) -50.7  (19.12) -48.1  (16.61)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Febuxostat Total
Hide Arm/Group Description Febuxostat 40 mg taken orally, once daily, based on serum urate level. Febuxostat 80 mg, taken orally, once daily, based on serum urate level Febuxostat 120 mg, taken orally, once daily, based on serum urate level [Not Specified]
All-Cause Mortality
Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Febuxostat Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Febuxostat Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/12 (25.00%)   14/116 (12.07%)   4/37 (10.81%)   21/116 (18.10%) 
Cardiac disorders         
Cardiac Conduction Disorders  1  0/12 (0.00%)  1/116 (0.86%)  0/37 (0.00%)  1/116 (0.86%) 
Supraventricular Arrhythmias  1  0/12 (0.00%)  5/116 (4.31%)  0/37 (0.00%)  5/116 (4.31%) 
Gastrointestinal disorders         
Duodenal and Small Intestinal Stenosis and Obstruction  1  0/12 (0.00%)  1/116 (0.86%)  0/37 (0.00%)  1/116 (0.86%) 
Gastrointestinal Ulcers and Perforation, Site Unspecified  1  0/12 (0.00%)  1/116 (0.86%)  0/37 (0.00%)  1/116 (0.86%) 
Intestinal Ulcers & Perforation not elsewhere classified (NEC)  1  1/12 (8.33%)  0/116 (0.00%)  0/37 (0.00%)  1/116 (0.86%) 
General disorders         
Pain and Discomfort NEC  1  0/12 (0.00%)  1/116 (0.86%)  0/37 (0.00%)  1/116 (0.86%) 
Hepatobiliary disorders         
Cholecystitis and Cholelithiasis  1  1/12 (8.33%)  1/116 (0.86%)  0/37 (0.00%)  2/116 (1.72%) 
Infections and infestations         
Abdominal and Gastrointestinal Infections  1  0/12 (0.00%)  1/116 (0.86%)  0/37 (0.00%)  1/116 (0.86%) 
Lower Respiratory Tract and Lung Infections  1  1/12 (8.33%)  1/116 (0.86%)  0/37 (0.00%)  2/116 (1.72%) 
Sepsis, Bacteraemia, Viraemia, and Infections  1  0/12 (0.00%)  1/116 (0.86%)  0/37 (0.00%)  1/116 (0.86%) 
Injury, poisoning and procedural complications         
Cerebral Injuries NEC  1  0/12 (0.00%)  0/116 (0.00%)  1/37 (2.70%)  1/116 (0.86%) 
Fractures and Dislocations NEC  1  0/12 (0.00%)  0/116 (0.00%)  1/37 (2.70%)  1/116 (0.86%) 
Non-Site Specific Injuries NEC  1  0/12 (0.00%)  1/116 (0.86%)  0/37 (0.00%)  1/116 (0.86%) 
Radiation Injuries  1  0/12 (0.00%)  1/116 (0.86%)  0/37 (0.00%)  1/116 (0.86%) 
Musculoskeletal and connective tissue disorders         
Intervertebral Disc Disorders  1  0/12 (0.00%)  0/116 (0.00%)  1/37 (2.70%)  1/116 (0.86%) 
Joint Related Disorders NEC  1  0/12 (0.00%)  1/116 (0.86%)  0/37 (0.00%)  1/116 (0.86%) 
Osteoarthropathies  1  0/12 (0.00%)  1/116 (0.86%)  1/37 (2.70%)  2/116 (1.72%) 
Pathological Fractures and Complications  1  0/12 (0.00%)  1/116 (0.86%)  0/37 (0.00%)  1/116 (0.86%) 
Spine and Neck Deformities  1  1/12 (8.33%)  0/116 (0.00%)  0/37 (0.00%)  1/116 (0.86%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lip and Oral Cavity Neoplasms Malignant  1  0/12 (0.00%)  1/116 (0.86%)  0/37 (0.00%)  1/116 (0.86%) 
Prostatic Neoplasms Malignant  1  0/12 (0.00%)  1/116 (0.86%)  0/37 (0.00%)  1/116 (0.86%) 
Respiratory Tract and Pleural Neoplasms Benign NEC  1  0/12 (0.00%)  1/116 (0.86%)  0/37 (0.00%)  1/116 (0.86%) 
Skin Neoplasms Malignant & Unspecified (Excluding Melanoma)  1  0/12 (0.00%)  0/116 (0.00%)  1/37 (2.70%)  1/116 (0.86%) 
Nervous system disorders         
Alzheimer's Disease (Including Subtypes)  1  0/12 (0.00%)  1/116 (0.86%)  0/37 (0.00%)  1/116 (0.86%) 
Central Nervous System Hemorrhages & Cerebrovascular Accidents  1  1/12 (8.33%)  0/116 (0.00%)  0/37 (0.00%)  1/116 (0.86%) 
Psychiatric disorders         
Depressive Disorders  1  1/12 (8.33%)  0/116 (0.00%)  0/37 (0.00%)  1/116 (0.86%) 
Renal and urinary disorders         
Bladder and Urethral Symptoms  1  1/12 (8.33%)  0/116 (0.00%)  0/37 (0.00%)  1/116 (0.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Febuxostat 40 mg QD Febuxostat 80 mg QD Febuxostat 120 mg QD Febuxostat Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/12 (41.67%)   44/116 (37.93%)   9/37 (24.32%)   53/116 (45.69%) 
Gastrointestinal disorders         
Diarrhoea  1  0/12 (0.00%)  9/116 (7.76%)  1/37 (2.70%)  10/116 (8.62%) 
Gastrointestinal Atonic and Hypomotility Disorders NEC  1  0/12 (0.00%)  5/116 (4.31%)  0/37 (0.00%)  5/116 (4.31%) 
Gastrointestinal Signs and Symptoms  1  0/12 (0.00%)  3/116 (2.59%)  1/37 (2.70%)  3/116 (2.59%) 
Nausea and Vomiting Symptoms  1  0/12 (0.00%)  2/116 (1.72%)  0/37 (0.00%)  2/116 (1.72%) 
General disorders         
Oedema NEC  1  0/12 (0.00%)  2/116 (1.72%)  0/37 (0.00%)  2/116 (1.72%) 
Injury, poisoning and procedural complications         
Skin Injuries NEC  1  0/12 (0.00%)  0/116 (0.00%)  1/37 (2.70%)  1/116 (0.86%) 
Investigations         
Liver Function Analyses  1  0/12 (0.00%)  4/116 (3.45%)  2/37 (5.41%)  6/116 (5.17%) 
White Blood Cell Analyses  1  0/12 (0.00%)  3/116 (2.59%)  0/37 (0.00%)  3/116 (2.59%) 
Triglyceride Analyses  1  0/12 (0.00%)  2/116 (1.72%)  0/37 (0.00%)  2/116 (1.72%) 
Blood Amylase Increased  1  1/12 (8.33%)  0/116 (0.00%)  0/37 (0.00%)  1/116 (0.86%) 
Weight Increased  1  0/12 (0.00%)  0/116 (0.00%)  1/37 (2.70%)  1/116 (0.86%) 
Blood Thyroid Stimulating Hormone Increased  1  0/12 (0.00%)  0/116 (0.00%)  1/37 (2.70%)  1/116 (0.86%) 
Metabolism and nutrition disorders         
Hyperlipidaemias NEC  1  1/12 (8.33%)  3/116 (2.59%)  0/37 (0.00%)  4/116 (3.45%) 
Musculoskeletal and connective tissue disorders         
Muscle Related Signs and Symptoms NEC  1  0/12 (0.00%)  3/116 (2.59%)  0/37 (0.00%)  3/116 (2.59%) 
Arthropathies  1  1/12 (8.33%)  1/116 (0.86%)  0/37 (0.00%)  2/116 (1.72%) 
Joint Related Signs and Symptoms  1  0/12 (0.00%)  2/116 (1.72%)  0/37 (0.00%)  2/116 (1.72%) 
Muscle Pains  1  0/12 (0.00%)  0/116 (0.00%)  2/37 (5.41%)  2/116 (1.72%) 
Musculoskeletal and Connective Tissue Signs and Symptoms NEC  1  0/12 (0.00%)  2/116 (1.72%)  0/37 (0.00%)  2/116 (1.72%) 
Nervous system disorders         
Headaches NEC  1  0/12 (0.00%)  5/116 (4.31%)  0/37 (0.00%)  5/116 (4.31%) 
Renal and urinary disorders         
Renal Lithiasis  1  1/12 (8.33%)  2/116 (1.72%)  0/37 (0.00%)  3/116 (2.59%) 
Skin and subcutaneous tissue disorders         
Rashes, Eruptions and Exanthems  1  1/12 (8.33%)  2/116 (1.72%)  0/37 (0.00%)  3/116 (2.59%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Sr VP, Clinical Science
Organization: Takeda Global Research & Development Center, Inc.
Phone: 800-778-2860
Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00174941     History of Changes
Other Study ID Numbers: TMX-01-005
U1111-1114-2039 ( Registry Identifier: WHO )
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: March 12, 2009
Results First Posted: July 16, 2009
Last Update Posted: January 27, 2011